Class II · Moderate risk Terminated
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes…
Reason Lack of sterility assurance.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium Sulfate 200 mg/mL
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Reason Lack of sterility assurance.
Class I · High risk Terminated
7K capsules packaged in single packs sold in 24-count boxes
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
POSEIDON Xtreme PLATINUM 4500
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk Terminated
My Way
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk Terminated
My Way
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk Terminated
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX
Reason Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Class II · Moderate risk Terminated
screamin' menthol
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk Terminated
screamin' hot
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk Terminated
Silver-Zinc Throat Spray
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk Terminated
Argentum Elixir Colloidal Silver
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk Terminated
Expectorant Cough Syrup
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk Terminated
Stomach Calm
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk Terminated
Intestinal Colic Drops
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk Terminated
Nausea Drops
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.